[{"data":1,"prerenderedAt":133},["ShallowReactive",2],{"content-site-settings":3,"content-index-en":49},{"id":4,"extension":5,"meta":6,"stem":47,"__hash__":48},"dataFiles\u002Fdata\u002Fsite.json","json",{"en":7},{"siteDetails":8,"cookieControl":12,"siteLogo":16,"mainNav":21,"preNav":35,"stickyNav":36,"footerContent":37},{"organisationName":9,"siteName":10,"siteUrl":11},"University of Birmingham","FREMS Study Site","https:\u002F\u002Ffrems-study.digitrial.com\u002F",{"cookieModalTitle":13,"cookieModalText":14,"nonNecessaryCookiesUsed":15},"Cookies used on this site","This website only uses non-necessary cookies to remember where you are in the process and to learn about how people view the information. We do NOT use cookies that directly identify anyone. For the best experience please click Accept all below.",true,{"url":17,"alt":18,"width":19,"height":20},"frems-logo.svg","Home",160,null,[22,25,29,32],{"title":23,"url":24},"Taking part","\u002Ftaking-part",{"title":26,"url":27,"target":28,"external":28},"About the study","\u002Fabout\u002F",false,{"title":30,"url":31},"Resources","\u002Fresources\u002F",{"title":33,"url":34,"target":28,"external":28},"Contact","\u002Fcontact\u002F",[],[],{"footerLogo":38,"footerCol1":43,"footerCol2":44,"footerCol3":45,"additionalInfo":46},{"url":39,"alt":40,"width":41,"height":42},"frems-footer-logo.svg","FREMS-PDPN study logo",352,180,"**Address**\\\nBirmingham Clinical Trials Unit\nPublic Health Building\nUniversity of Birmingham\nBirmingham B15 2TT","**Telephone**\\\n+44 (0)121 415 9128\n\n**Email**\\\nfrems-pdpn@trials.bham.ac.uk\n\n**Social**\\\n\u003Ca href=\"https:\u002F\u002Ftwitter.com\u002Ffrems_pdpn\" target=\"_blank\">Twitter\u003C\u002Fa>","[Privacy policy](\u002Fprivacy)\n[Cookie policy](\u002Fcookies)\n[Accessibility statement](\u002Faccessibility)\n[Site map](\u002Fsite-map)","This study is funded by the National Institute for Health Research (NIHR) Heath Technology Assessment programme (project reference NIHR133599). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.\n\nThis is a digitrial site made by morph.co.uk.","data\u002Fsite","QR5K9ahYGZL5PI7YZmCR5PWFEX7nQcULbzd1RZ6iEQo",{"id":50,"title":51,"body":20,"description":20,"extension":5,"meta":52,"navigation":15,"path":129,"seo":130,"stem":131,"__hash__":132},"contentPages\u002Fpages\u002Findex.en.json","Home page",{"pageTitle":53,"pageMetadata":54,"page_content":55},"The FREMS-PDPN Study",{"htmlTitle":53,"htmlDesc":53},[56,71,81,92],{"type":57,"title":58,"text":59,"image":60,"settings":65,"sectionSettings":67},"page_header","# The FREMS-PDPN Study","Evaluating the efficacy of FREMS (Frequency Rhythmic Electrical Modulated System) in patients with painful diabetic peripheral neuropathy (PDPN, painful feet from nerve damages caused by diabetes)",{"url":61,"alt":62,"width":63,"height":64},"frems-header-image-6@2x.png","",576,412,{"imgWidth":66},"half-width",{"sectionLabel":68,"customClass":69,"theme":70},"The TRIAL Study","page_header_bg_2","primary",{"type":72,"text":73,"video":74,"sectionSettings":79},"text_and_video","## The FREMS-PDPN Study Participant Information Animation\n\nDiabetes Mellitus (DM) is very common in the UK and globally and is a major health care challenge for the NHS. Diabetes UK announced that the number of people living with DM in the UK has more than doubled over the last 20 years.\n\nPainful Diabetes-related Peripheral Neuropathy (PDPN) is a serious complication affecting 20-26% of patients with DM.\n\nWith an increasing prevalence of DM, the prevalence and burden of PDPN is likely to increase further over the next decade, which will pose a major treatment and financial challenge.\n\n\n\nPlease watch our animation to find out more about the FREMS-PDPN study.",{"vimeoId":75,"videoTitle":76,"videoTranscript":77,"offlineVideo":62,"offline_video_thumbnail":78},"803426826\u002Fc37197382f","FREMS-PDPN Participant Information Animation","The FREMS-PDPN Study is looking at whether a nerve stimulation device can reduce pain from the nerve damage diabetes can cause. \n\nPeripheral Neuropathy happens because of nerve damage in the feet and legs. \n\nThis causes pain and discomfort that can badly affect sleep and quality of life. \n\nThe standard treatment for nerve pain is medication but it doesn’t work for everyone. \n\nIn this trial we are testing a treatment called FREMS. \n\nFREMS is like TENS treatment, which is already used in the NHS for pain relief. \n\nIt uses the same kind of device, with pads stuck to the skin giving electrical pulses that stimulate the nerve ends. \n\nEvidence suggests FREMS and TENS both work for pain in the short term. \n\nAnd both are safe. \n\nThe difference is that FREMS delivers a different, changing electrical pulse. \n\nWe hope this trial will tell us if FREMS helps nerve pain better and for longer than TENS. \n\nIf you would like to take part we will screen you to see if the study is suitable for you. \n\nFirst, you’ll need to give consent using an online form. \n\nWe will check your medical records. \n\nWe will ask you to complete a 7 day pain diary, sending us a daily score by text message. \n\nAfterwards, if you are eligible we will arrange your first visit in person. At this visit you can ask any questions. \n\nYou can then take your time to decide what you would like to do. \n\nIf you decide to join the study...you will be asked to sign another online consent form. \n\nAnswer some questions about your medical history. \u2028\n\nComplete questionnaires about your pain, sleep, mood, general health and wellbeing. \n\nAnd we will do some tests. \n\nIf your doctor thinks the study is right for you, you will be randomly allocated to your treatment. Half to FREMS, half to TENS. \n\nNeither you nor your doctor will know which you receive. \n\nThe rest of your care will continue as normal. \n\nThe treatment involves 10 sessions at hospital over two weeks, each about 40 minutes. \n\nThe electric pulse level is set by the nurse, based on how you feel. \n\nUsually the electrical stimulation can be felt as a kind of buzzing, but it shouldn’t be painful. \n\nWe will ask you to send us your daily pain scores for 6 months. \n\nIn the final treatment session we will ask you to complete the questionnaire again. \n\nThis will be repeated in visits at three and six months after the treatment, where we will also check your progress and carry out a final medical. \n\nJoining this study is completely voluntary and you can leave at any time.\u2028\n\nYour decision will not affect the standard of care you receive. \n\nThe study team will be happy to answer any questions you may have.","frems-logo.png",{"sectionLabel":80},"DRIFT Participant Information Animation",{"type":82,"settings":83,"title":85,"text":86,"image":87,"sectionSettings":90},"text_and_image",{"imgWidth":66,"imgPosition":84},"top","## Background","PDPN affects a quarter of people with diabetes and 70% of sufferers have moderate-to-severe foot pain. This pain results in in sleep disruption, poor quality of life (QoL), unemployment and depression. The average health care cost for each patient with PDPN in the UK was estimated to be £2,511 per year, which increases with greater pain severity. The burden of PDPN is likely to increase as diabetes becomes more common.\n\nNICE guidance 173 recommended certain medications as initial treatments for PDPN. However, using these medications results in 50% reduction in pain in one third of patients at best. These medications also have multiple side effects such as nausea, sedation, dizziness, dry mouth, weight gain, falls, constipation and more.\n\nBeyond these drugs, there are no NICE recommended treatments. As a result, many patients receive opioids (43%), which has many unwanted side effects including addiction. Hence, there is a clear need to identify an effective, safe, well-tolerated, non-invasive intervention that is good value for money in those who fail to respond to NICE recommended treatments. This could reduce medications and opioid use & improve QoL.",{"url":88,"alt":62,"width":63,"height":89},"frems-content-image-1-1000w.png",377,{"sectionLabel":91},"Background",{"type":93,"settings":94,"cards":97,"sectionSettings":127},"text_and_cards",{"headerLevel":95,"headerFontSize":95,"maxCardsPerRow":95,"wholeClickable":15,"numberedCards":28,"cardTheme":70,"alignCards":96,"alignCardContent":96},"3","left",[98,109,118],{"type":99,"image":100,"title":104,"summary":105,"links":106},"card_image_text",{"url":101,"width":102,"height":103},"frems-card-image-1.svg",1000,640,"Taking Part","Find out more about taking part in the study",[107],{"title":108,"url":24,"external":28,"target":28},"Go to 'Taking Part'",{"type":99,"image":110,"title":112,"summary":113,"links":114},{"url":111,"width":102,"height":103},"frems-card-image-5.svg","About the Study","Learn more about the study",[115],{"title":116,"url":117},"Got to 'About the Study'","\u002Fabout",{"type":99,"image":119,"title":121,"summary":122,"links":123},{"url":120,"width":102,"height":103},"frems-card-image-3.svg","Contact Us","Get in touch with the study team",[124],{"title":125,"url":126},"Get in touch","\u002Fcontact",{"sectionLabel":128},"Benefits of screening for type 1 diabetes:","\u002Fpages\u002Findex.en",{"title":51},"pages\u002Findex.en","mD4P5-eMSGgxX573Chcovv1k9RWRWdf0jFn7LqED6aA",1789397910742]